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Feasibility Study of Closed Loop Control in Type 1 Diabetes Using Heart Rate Monitoring as an Exercise Marker

NCT01582139 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-08-15

Study results available
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Summary

The purpose of this study is to see if the Artificial Pancreas Platform (AP Platform = Cell Phone + Closed Loop Control) can successfully control blood sugar in people with type 1 diabetes mellitus on insulin pump therapy in a hospital setting. Investigators will also be studying to see if information about heart rate can help the AP Platform reduce hypoglycemia related to exercise.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

Heart rate informed SSM+HMM

The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • DexCom, Inc.

    collaborator INDUSTRY

  • Insulet Corporation

    collaborator INDUSTRY

  • Abbott Diabetes Care

    collaborator INDUSTRY

  • University of Virginia

    lead OTHER

Principal Investigators

  • Marc Breton, Ph.D. · University of Virginia Center for Diabetes Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01582139 on ClinicalTrials.gov